Ph. Eur updates heparin reference substances

Staff reporter

23-Jul-2010

Heparin bottles x 2 The European Pharmacopeia (Ph. Eur.) has developed four chemical reference substances to be used alongside two new monographs for heparin calcium and heparin sodium which are due to come into force on August 1, 2010.

The first three reference substances - heparin for physico-chemical analysis; heparin sodium for NMR identification; and heparin calcium for NMR identification - were made available on July 15. The fourth - dermatan sulfate and over-sulfated chondroitin sulfate - will be available from August 1.

The Europe Directorate on the Quality of Medicines (EDQM), which publishes Ph. Eur., has been revising its heparin reference standards in the wake of the contamination of heparin products with OSCS which claimed more than 200 lives around the world in 2008.

More information is available here.

Related articles:

FDA under fire for handling of heparin crisis

USP student award goes to heparin analysis project

FDA publishes Q&A doc on heparin monograph

New USP heparin standards now in force

Two more Chinese companies linked to tainted heparin

Features
Showcase
Research
Events

Wellcome Trust backs counterfeit drug analysis project
The Wellcome Trust has awarded £473,000 ($737,000) in funding to researchers in the UK and Sweden to create a low-cost instrument that can screen medicines for quality and authenticity.
Start-up aims to make pharma cargo tamper-proof
A security system to protect cargo containers and pallets from theft and tampering is promising to improve security in the pharmaceutical sector.
Brazil may swap its serialisation scheme for Turkish model
Brazil may back away from its current plans for a national serialisation system for drugs and adopt one closer to the Turkish model.